Quality Choice 44-226

Quality Choice 44-226

Drug Labeling and Warnings

Drug Details

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STAY AWAKE- caffeine tablet 
CHAIN DRUG MARKETING ASSOCIATION INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Quality Choice 44-226

Active ingredient (in each tablet)

Caffeine 200 mg 

Purpose

Alertness aid 

Uses

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness 

Warnings

For occasional use only

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. 

Do not use

  • in children under 12 years
  • as a substitute for sleep 

Stop use and ask a doctor if

fatigue or drowsiness persists or continues to recur. 

If pregnant or breast-feeding,

ask a health professional before use. 

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. 

Directions

  • adults and children 12 years and over: take 1 tablet not more often than every 3 to 4 hours 

Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, dextrose, dicalcium phosphate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silica gel 

Questions or comments?

1-800-426-9391 

Principal Display Panel

NDC: 63868-114-16

QC®
QUALITY
CHOICE

*Compare to the
Active ingredient in 
VIVARIN®

Stay Awake

Caffeine 200 mg
Alertness Aid
Equal to About a Cup of Coffee

actual
size

16 Tablets

*This product is not manufactured or distributed by Meda Consumer Healthcare, owner of the registered trademark Vivarin®.
50844      REV0412A22621

SATISFACTION
GUARANTEED
100%
QC

Distributed by C.D.M.A., Inc©
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Questions: 248-449-9300 

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Quality Choice 44-226

Quality Choice 44-226

STAY AWAKE 
caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63868-114
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
DEXTROSE (UNII: IY9XDZ35W2)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 44;226
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63868-114-405 in 1 CARTON11/21/1996
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 63868-114-162 in 1 CARTON11/21/1996
28 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34011/21/1996
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(63868-114)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(63868-114)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(63868-114)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(63868-114)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(63868-114)

Revised: 3/2019
 
CHAIN DRUG MARKETING ASSOCIATION INC


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